Functional Near Infra-Red Spectroscopic Study of Central Auditory System Cortical Functional Reorganization

NCT04043910 | Completed

• 1 other identifier: RC31/17/0321
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the auditory cortical activity in response to monaural and binaural stimuli, measured by functional Near-Infrared Spectroscopy (fNIRS) between Single-sided Deaf (SSD) Children, and Normal-Hearing (NH) children from 5 to 16 years. Binaural audiological performance, speech skills and quality of life (QoL) will be compared between the 2 groups and links to with the cortical activity will be assessed.

Conditions

Hearing Loss, Unilateral

Keywords

Functional Neuroimaging; Pediatrics; fNIRS; Single-sided deafness

Outcome Measures

Primary Outcomes (2)

• Oxyhemoglobin rates

  Oxyhemoglobin (O2Hb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.

  3 months

• Deoxyhemoglobin rates

  Deoxyhemoglobin (HHb) rates measured on the auditory cortex of each cerebral hemisphere during an auditory stimulus.

  3 months

Secondary Outcomes (5)

• Binaural audiological performances

  3 months

• Speech assessment

  3 months

• Quality of life scores

  3 months

• Quality of life scores

  3 months

• Activity levels

  3 months

Study Arms (2)

Single-sided deaf group

EXPERIMENTAL

30 children will be included in this group

Device: fNIRS; Other: Speech intelligibility; Other: Sound localisation; Other: Speech assessments; Other: Quality of Life

Normal hearing group

ACTIVE COMPARATOR

30 children will be included in this group

Device: fNIRS; Other: Speech intelligibility; Other: Sound localisation; Other: Speech assessments; Other: Quality of Life

Interventions

Quality of Life OTHER

Quality of Life (QoL) evaluation will be based on the generic QoL scale, and the Speech Spatial and Qualities of hearing (SSQ) deafness specific scale. Each scale exists in age specific modalities.

Normal hearing group; Single-sided deaf group

fNIRS DEVICE

The auditory cortical imaging will be performed by fNIRS measures. This non-invasive functional imaging technique relies on the use of a sensor-bearing cap, measuring cortical activity through scalp, during auditory stimulation. As head movement does not alter measurement that much, fNIRS is well adapted to children.

Normal hearing group; Single-sided deaf group

Speech intelligibility OTHER

Speech intelligibility will be evaluated with French sentences comprehension in noise, from the Common Test or Adaptive Auditive Speech Test before 6 years, from the Common Test or Hearing in Noise Test for Children (Hint-C) from 7 to 11 years, and from the Hint-C or Marginal Benefit of Acoustic Amplification after 11 years, both with a Signal over Noise Ratio of +10 decibel at 65 decibel

Normal hearing group; Single-sided deaf group

Sound localisation OTHER

Sound localisation will be evaluated with a left-right discrimination test before 7 years and a 12 loudspeakers sound localisation test after 7 years.

Normal hearing group; Single-sided deaf group

Speech assessments OTHER

Speech assessments will be performed by dedicated speech therapists, with child age specific tests, and 2 global speech scores: the Category of Auditory Performances scale - second edition, and the Speech Intelligibility Rating scale.

Normal hearing group; Single-sided deaf group

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For both groups:
• to 16 year-old children,
• Absence of pregnancy
• Affiliation to Social Security, and children and their parents signed consents will be necessary.
• Participation agreement of the protocol and signature of the consent form by the person having parental authority and the child
• For Single-sided Deafness subjects:
• \- shall present with moderate to profound unilateral hearing loss, with a hearing loss of 40 decibel(minimal thresholds), assessed on tonal, vocal audiometry, Auditory Brainstem Responses,
• For Normal hearing subjects:

You may not qualify if:

• For both groups:
• Antecedents of Psycho-neurological diseases,
• Other sensorineural or motor deficiency,
• Familial bilingualism,
• Medications affecting vigilance.
• pregnancy or breastfeeding

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Hôpital Pierre Paul Riquet

Toulouse, 31059, France

Location

Related Publications (1)

• Calmels MN, Gallois Y, Marx M, Deguine O, Taoui S, Arnaud E, Strelnikov K, Barone P. Functional Reorganization of the Central Auditory System in Children with Single-Sided Deafness: A Protocol Using fNIRS. Brain Sci. 2022 Mar 22;12(4):423. doi: 10.3390/brainsci12040423.

  PMID: 35447955 RESULT

MeSH Terms

Conditions

Hearing Loss, Unilateral

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Marie-Noëlle CAMELS

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: August 2, 2019
• Study Start: April 17, 2018
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

FR (1)